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The facility for Regulatory
Toxicology offers full range of "systemic"
and "specialised" toxicity studies
in conformity with the requirements of international
regulatory bodies for development of new
(synthetic or herbal) drugs and vaccines.
The existing infrastructure is the only
place of its kind in India which offers
complete facilities under one roof.
Protocols followed by CDRI
for toxicity studies are based on the guidelines
for toxicity testing of chemicals issued
by the Organisation for Economic Co-operation
and Development (OECD), France. However,
our approach is quite flexible and quite
comprehensive, it adapts to changes
quickly and complies with the requirements
of other important regulatory bodies as
well.
Over the past forty years,
we have carried out the toxicity studies
on more than fifty candidate drugs and vaccines.
Our regulatory toxicity facility is complemented
and backed by a well stocked in-house animal
facility.
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The regulatory toxicity
studies are being conducted in compliance
with the norms of GLP prescribed by the OECD.
Toxicity testing facility at CDRI is of adequate
size, construction, location, etc. to meet
the requirements of different types of studies.
All personnel involved in studies have had
adequate training and experience in their
respective areas of specialization. Apparatuses
and equipments arc of adequate quality and
capacity to meet the requirements of the toxicity
testing protocols.
There also exist adequate facilities for
procedures designed to ensure the identity,
purity, stability, composition etc. of test
materials to be used in studies.
Standard Operating Procedures (SOPs) have
been developed and held in place to ensure
GLP compliance. These procedures cover instructions
from the simplest to the most intricate
of scientific techniques. Protocols of all
studies are strictly followed during the
course of the study; any deviation from
protocol is recorded in appropriately numbered
amendments.
All records, appropriate samples and reports
are properly maintained for archival use.
Toxicity study reports cover information
such as objective of study, full details
of the composition and stability of the
test substance, a description of the test
system in used, summary of findings, etc.
and are signed by the Study Director and
senior staff and consultants.
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